FDA Drug Safety Communication

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FDA Date: 12/11/11

FDA Drug SafetyCommunication on Medications used to treat Attention-Deficit/Hyperactivity Disorder

Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults

FDA is updating its communication on the ongoing cardiovascular safety review of medications used for treating attention-deficit/hyperactivity disorder (ADHD), many of which are known to increase heart rate and blood pressure. A large, recently-completed review that included one study that evaluated heart attacks and sudden deaths in a sample of adults and a second study that assessed strokes in these adults has not shown an increased risk of serious adverse cardiovascular events in adults treated with ADHD medications.

The medications studied include stimulants (amphetamine products and methylphenidate), atomoxetine, and pemoline (no longer marketed).

FDA recommendations for the use of medications to treat ADHD have not changed. Healthcare professionals should continue to take special note that:

- Stimulant products and atomoxetine should, generally, not be used in patients with serious heart problems, or for whom an increase in blood pressure or heart rate would be problematic.

- Patients treated with ADHD medications should be periodically monitored for changes in heart rate or blood pressure.

- Patients should continue to use their medicine for the treatment of ADHD as prescribed by their healthcare professional.

In the two recently completed epidemiologic studies, data were analyzed from over 440,000 adults aged 25-64 years, including over 150,000 adults treated with medications for ADHD. One study evaluated heart attacks and sudden cardiac deaths in this sample of adults, and the second study assessed strokes in these adults. Together, these studies were designed to evaluate the potential increased risk of heart attack (myocardial infarction, or MI), sudden cardiac death, or stroke that could be associated with the use of ADHD medications. The adult study is being published in the Journal of the American Medical Association on December 12, 2011.

On November 1, 2011, FDA communicated the results of a study in children and young adults treated with ADHD medications that also did not show an increased risk of serious cardiovascular events. This study was published in the New England Journal of Medicine on November 1, 2011.

1. Habel LA, Cooper WO, Sox CM, et al. ADHD medications and risk of serious cardiovascular events in young and middle-aged adults. JAMA. 2011;306(24):2673-2683. Epub 2011 Dec. 12.

2.Cooper WO, Habel LA, Cox CM, et al. ADHD drugs and serious cardiovascular events in children and young adults. N Engl J Med. 2011;365(20):1896-1904. Epub 2011 Nov 1.

View the full FDA Drug Safety Communication on FDA.gov